RECRUITING

Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious postoperative outcomes in the geriatric surgical population. The goal of this clinical trial is to determine whether intravenous anesthesia (IV) leads to a decreased incidence of postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and functional decline, and improved patient-reported outcomes (PROs) in older adults undergoing non-cardiac surgery when compared to the standard inhalational anesthesia (GAS). This single-center, 1:1 randomized, double-blind (patient \& outcome assessor) clinical trial will compare inhalational vs. intravenous anesthesia on POD, POCD, functional status, patient-reported outcomes (PROs), and blood-based biomarkers in older patients undergoing elective, inpatient, non-cardiac surgery. Upon enrollment, 260 women and men ≥ 70 years undergoing elective noncardiac surgery under general anesthesia will be randomized to 2 groups: TIVA or GAS.

Official Title

Optimizing Anesthesia to Prevent Postoperative Cognitive and Functional Decline in Older Adults: A Randomized Controlled Trial

Quick Facts

Study Start:2023-08-14
Study Completion:2027-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06036095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:70 Years to 110 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women ≥ 70 years
  2. * Sufficient vision and hearing to complete all tests
  3. * Proficient in spoken and written English
  4. * Scheduled for elective, inpatient, noncardiac surgery, expected to last at least 120 minutes requiring general anesthesia
  1. * Urgent or emergent surgery
  2. * Diagnosed dementia (or MoCA\<19)
  3. * History of Parkinson's disease, major psychiatric disease (Schizophrenia), or severe traumatic brain injury
  4. * Ongoing alcohol or substance abuse (per DSM V criteria)
  5. * Allergy to propofol or sevoflurane
  6. * Personal or family history of malignant hyperthermia
  7. * Planned postoperative intubation
  8. * Brain surgery
  9. * Surgery requiring TIVA or GAS (i.e. cases involving neuromonitoring)
  10. * Surgical procedure requiring general anesthetic occurring within 3 months (before or after) surgical date
  11. * Any patient or perioperative factor considered a contraindication to randomization to either experimental group by the surgeon or anesthesiologist.

Contacts and Locations

Study Contact

Kimberly N. Chun, BS
CONTACT
503-494-7437
chunk@ohsu.edu
Sarah L. Feller, BS
CONTACT
503-494-6233
fellersa@ohsu.edu

Principal Investigator

Katie J. Schenning, MD
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Katie J. Schenning, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-14
Study Completion Date2027-03-15

Study Record Updates

Study Start Date2023-08-14
Study Completion Date2027-03-15

Terms related to this study

Additional Relevant MeSH Terms

  • Neurocognitive Disorders
  • Anesthesia
  • Post-operative Delirium
  • Post-operative Cognitive Dysfunction